This attractive Dossier Conformance Manager job is a great opportunity to join one of the pharma industry's biggest and most prestigious organisations. The company is located in South London and has been working for over a 150 year across multiple therapy areas including cardiovascular, neurology and immunology. The Dossier Conformance Manager will perform conformance assessment between manufacturing documents and in-market dossiers filed with Europe and Emerging Markets Europe local Health Authorities, focusing on Module 3. They will be committed to quality and excellence in compliance and conformance and ensure the timely communication of any issues. This is a contract role based in Tadworth, Surrey.
- Data collection and evaluation in preparation for product and market assessment.
- Perform conformance analysis of source dossier with market dossier
- Ensure compliance systems accurately reflect market approval and manufacturing practices
- Operate to the highest conformance standards
- Operate in line with internal SOPs and policies
- Liaise with regulatory colleagues to communicate and resolve potential issues
Skills and Requirements:
- Bachelor’s degree or equivalent i.e. degree in Chemistry, Pharmacy, or a related life science.
- Experience in a quality or compliance role within the pharmaceutical industry - minimum 3 years of experience.
- Strong compliance focus and understanding
- Good knowledge of content and requirements for CTD Module 3
- Attention to detail
- Demonstrated experience with a pharmaceutical company with proven examples of contribution.
- Knowledge and understanding of quality systems, processes, audit and inspection
- Experience with maintaining electronic systems and databases
- Knowledge on general standards, processes and policies of Pharmaceutical Manufacturing Industry
- Good communication and interpersonal skills
- Team player
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Numhom Sudsok on +44 203 8718 093 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.